Beyfortus (nirsevimab or nirsevimab-alip) is an injection used to prevent illness due to respiratory syncytial virus (RSV) for children up to 24 months old. It's a monoclonal antibody that provides short-term protection against the virus, so it's meant to be given during or at the start of the RSV season. It's well-tolerated and doesn't have many side effects. Beyfortus (nirsevimab) was approved by the FDA in July 2023, and is expected to be available for the upcoming 2023-2024 RSV season.
Prevention of respiratory syncytial virus (RSV) in:
Newborns and infants during or entering their first RSV season
Children up to 24 months old at risk for severe RSV illness through their second RSV season
Beyfortus (nirsevimab) is an injection of monoclonal antibodies (manmade proteins) which provides protection against the respiratory syncytial virus (RSV). The antibodies attach to the virus and stop it from entering cells and spreading.
Source: DailyMed
Side effects that you should report to your care team as soon as possible:
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Given as a single dose
Lowers the risk of severe RSV-related illness by about 70% in premature babies
Not many side effects
Not studied in children older than 24 months
Injection can be uncomfortable
No lower-cost generic available
Your child should get Beyfortus (nirsevimab) at the start of or during the RSV season, which is typically late fall to early spring. Ask your child's provider about when RSV season begins in your area, so you can plan your child's dose.
If your child receives Beyfortus (nirsevimab) for their first RSV season and continues to be at a higher risk for RSV, ask your child's provider about getting a second dose for their second RSV season.
Even though Beyfortus (nirsevimab) can lower your child's risk of RSV infection, it's possible for your child to still get infected and become ill. Watch out for symptoms of RSV, including a runny nose, cough, and sore throat.
If your child has heart surgery, your child's provider might need to give your child an additional dose of Beyfortus (nirsevimab) afterwards.
The most common side effects of Beyfortus (nirsevimab) are rash, pain, and swelling at the site of the injection. Talk with your child's provider about ways to give your child relief.
Beyfortus (nirsevimab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Severe and life-threatening allergic reactions, including anaphylaxis, have happened with other monoclonal antibody products similar to Beyfortus (nirsevimab). If your child seems to be having trouble breathing, or you notice a severe rash or swelling in their face, get medical help right away.
Risk factors: History of bleeding problems | Taking blood-thinning medication
Let your child's provider know if they have a history of bleeding problems, like low platelets. Also make sure to give them a list of your child's current medications, so they can check if they're taking any blood-thinning medications. Your child might still be able to receive Beyfortus (nirsevimab), but their provider will want to monitor them more closely for bleeding after the injection.
Beyfortus (nirsevimab) is injected into the muscle by a trained healthcare provider.
Newborns and infants born during or entering their first RSV season:
Weight less than 5 kg (11 lbs): The typical dose is 50 mg given as one dose.
Weight 5 kg (11 lbs) and more: The typical dose is 100 mg given as one dose.
Children up to 24 months old at risk for severe RSV illness in their second RSV season:
The typical dose is 200 mg given as two 100 mg injections in one office visit.
Prevention of respiratory syncytial virus (RSV) in:
Newborns and infants during or entering their first RSV season
Children up to 24 months old at risk for severe RSV illness through their second RSV season
Babies born premature and are 6 months or younger at the start of RSV season
Children diagnosed with bronchopulmonary dysplasia (BPD) within the last 6 months, and are 2 years or younger at the start of RSV season
Children with congenital heart disease (CHD) and are 2 years or younger at the start of RSV season
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AstraZeneca plc. (2023). Beyfortus approved in the US for the prevention of RSV lower respiratory tract disease in infants.
Centers for Disease Control and Prevention. (2024). For healthcare providers.
Sanofi Pasteur Inc. (2023). Beyfortus- nirsevimab injection [package insert]. DailyMed.
Sun, M., et al. (2023). Monoclonal antibody for the prevention of respiratory syncytial virus in infants and children: A systematic review and network meta-analysis. JAMA Network Open.
U.S. Department of Health and Human Services. (2022). Vaccine types.
U.S. Food and Drug Administration. (2023). FDA approves new drug to prevent RSV in babies and toddlers.
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